1999 Yes Total Quality Management High School West Brabant. Year Award Course Qualifying authority
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1 Resume/CV Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963 Home or correspondence address Street and number : Van Leeuwenhoeklaan 16 Postcode : 5252 CC City: Vlijmen Country : The Netherlands Tel. No. : +31(0) Mobile Phone no. : +31(0) leo.besselaar@lbqconsultancy.nl Business details Part-time job (50%) TüV Rheinland Name of Organisation TüV Rheinland Nederland BV Address PO Box 541 Postcode : 7300 AM City: Apeldoorn Country: The Netherlands Tel. no. : +31(0) Fax no. : +31(0) Mobile Phone no. : +31(0) Leo.van.den.Besselaar@nl.tuv.com My own 1 st consultancy office Name of Organisation LBQ Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Mobile Phone no. : +31(0) leo.besselaar@lbqconsultancy.nl Internet: My own 2 nd consultancy office Name of Organisation GMP TopConsult BV Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Mobile Phone no. : +31(0) leo.besselaar@gmptopconsult.nl Internet: CV-LvdB-July-2011 Page 1 of 6
2 Academic and Technical Qualifications Year Award Course Qualifying authority Yes Intermediate Vocational Education Analytical Chemistry Yes Higher Vocational Education Analytical Chemistry High School Eindhoven High School West Brabant 1999 Yes Total Quality Management High School West Brabant (Auditor) Year Award Course Qualifying authority 1998 Yes Internal Auditing I Dutch Normalisation Institute (NEN) 1998 Yes Internal Auditing II Dutch Normalisation Institute (NEN) 1998 Yes GMP Compliance auditing Pharmaceutical Compliance Associates, Stockholm 1999 Yes Internal auditing ISO 9001 High School West Brabant 2001 Yes ISO 9001:2000 Series Auditor / Lead Auditor Course BVQI 2003 Yes GMP Feed PDV Yes IRCA QMS Lead Auditor IRCA, Registration number NA Lean Six Sigma TNO Management Consultants 2008 Yes Lead Auditor IKM 3000, complaint management Foundation IKM Yes 3 Day GMP Conference Pharmatech 2009 NA Chain Management TNO Management Consultants 2010 Yes Integration OHSAS and ISO 9001 Dutch Normalisation Institute (NEN) 2010 Yes 3 Day GMP Conference Pharmatech 2010 Yes Social Responsibility ISO Dutch Normalisation Institute (NEN) 2011 Yes Risk Management ISO Dutch Normalisation Institute (NEN) 2011 Yes Cosmetics GMP ISO SGS CV-LvdB-July-2011 Page 2 of 6
3 Specific knowledge of Standard and Guidelines Standard / Guideline ISO ISO EFfCI EXCIPACT TM IPEC ICH Q7 ICH Q10 Standard / Guideline ISO HACCP EFMC Standard / Guideline ISO 9001 ISO 9004 ISO ISO OHSAS ISO ISO Medical Devices / Cosmetics / Pharmaceuticals Medical Devices Cosmetics Good Manufacturing Practices GMP Guide for Cosmetic Ingredients Pharmaceutical Excipients : GMP and GDP Good Manufacturing Practices Guide for Pharmaceutical Excipients Active Pharmaceutical Ingredients Good Manufacturing Practices Pharmaceutical Quality System Food & Feed Safety Food Safety Management Systems Food Safety Management Systems European Feed Manufacturers Guide Sundries Quality Management Systems Managing for sustained success of an organization Environmental Management Systems Testing & Calibration Laboratories Management Systems Occupational Health & Safety Management Systems Social Responsibility Risk Management Systems Work Experience Year Job Title Company Chemical Analyst Diosynth BV (Akzo Nobel) Team leader Analytical Methodology Diosynth BV (Akzo Nobel) QC Manager Diosynth BV (Akzo Nobel) Quality Auditor Diosynth BV (Akzo Nobel) Quality System Manager Diosynth BV (Akzo Nobel) International Quality System Manager Diosynth BV (Akzo Nobel) Global QHSE Manager API-manufacturing Organon NV (Akzo Nobel) Interim Business Unit Manager TNO Certification BV Lead Auditor System Certification TNO Certification BV to day Lead Auditor System Certification ISO 9001, ISO22000, HACCP TüV Rheinland Nederland CV-LvdB-July-2011 Page 3 of 6
4 Work Experience as consultant Year Job Title Company to-day Consultant Management Systems & Audits LBQ to day Managing Director / Consultant GMP TopConsult BV to day Trainer Internal Auditing NEN to day Trainer Laboratory Management Systems Avans+, improving professionals Specific Auditing en Inspection Experience Type of audits/inspections Internal audits System Certification Audits Customer Audits GMP Inspections Activities Performance of ± 100 internal audits within different kind of companies Performance of ± 100 supplier audits covering all kinds of products and services: contract laboratories, cosmetic and API-manufacturers, solvents, chemicals, equipment Performance of ± 300 system certification audits based on ISO 9001,ISO and HACCP, ISO 22716, GMP+ Feed Safety Guidance of ± 50 customer audits for customers of Diosynth BV buying Biochemical, Chemical and Biotechnological API s Guidance of 15 GMP inspections for Diosynth BV: - FDA inspections in the Netherlands and Diosynth SA in France. - MHRA inspection within Diosynth Ltd in Scotland. - Inspections of the Dutch authorities within Diosynth BV in the Netherlands. CV-LvdB-July-2011 Page 4 of 6
5 References LBQ / GMP TopConsult Company Activity Abalco Service Akzo Nobel Chemicals Avans+, improving professionals Banner Pharmacaps Budelpack CML Europe FAMAR Nederland GlaxoSmithKline Janssen Animal Health Innogenetics Internal audits / training / FDA project KIWA Certification System Certification GMP+ Feed Safety Magma IT Solutions MSD Mondial Pack NEN Nestlé Nutrition / FDA project Nutrilab / internal audits Organon NV Pharma Consulting & Industries Pharmaceutical Services Pharmatech Peter Greven Schering-Plough Schouten Internal audits SQA Services SGS / System Certification ISO TNO Certification System Certification ISO 9001, ISO 22000, HACCP Van de Wiel Beveiliging / internal audits Van Loosbroek Farma Consult Van Meeuwen Interim Management Vion Food Group - SONAC / FDA project CV-LvdB-July-2011 Page 5 of 6
6 Examples of the performed Supplier Audits Company Country Product Chimica Sintetica Spain Active Pharmaceutical Ingredients Diosynth BR Brazil Active Pharmaceutical Ingredients Diosynth Inc USA Active Pharmaceutical Ingredients Diosynth LTD Scotland Active Pharmaceutical Ingredients Diosynth SA France Active Pharmaceutical Ingredients Euticals S.p.A. Italy Active Pharmaceutical Ingredients Finaf-92 Spain Active Pharmaceutical Ingredients Heumann Germany Active Pharmaceutical Ingredients Moehs SA Spain Active Pharmaceutical Ingredients Sanofi-Synthelabo France Active Pharmaceutical Ingredients SelocFrance France Active Pharmaceutical Ingredients Sifa Ltd Ireland Active Pharmaceutical Ingredients Sun Pharmaceuticals India Active Pharmaceutical Ingredients Miavit GmbH Germany Animal Health Products Protexin Ltd England Animal Health Products Provimi Lld England Animal Health Products VTA GmbH Germany Cosmetic Ingredients Bruno Bock Germany Acids Dex Plastomers The Netherlands Polymers DSM/DSI The Netherlands Pharmaceutical Intermediates Life Technologies Scotland Cell Cultures Linde Gas Benelux The Netherlands Liquid Gasses Merck KGaA Germany Chemicals PVS Chemicals Belgium Acids Analytico The Netherlands Contract Laboratory MTL Scotland Contract Laboratory Organon Teknika The Netherlands Contract Laboratory Saybolt Nederland BV The Netherlands Contract Laboratory SGS The Netherlands Contract Laboratory BASF Germany Solvents DOW Deutschland GmbH Germany Solvents Helm AG Germany Solvents Heybroek The Netherlands Solvents Univar Belgium Solvents Methanex Europe Belgium Solvents Methanor The Netherlands Solvents Alloga The Netherlands Storage & Distribution (Pharmaceuticals) Caldic Europoort BV The Netherlands Storage & Distribution (Solvents) Organon The Netherlands Storage & Distribution (Pharmaceuticals) Vopak The Netherlands Storage & Distribution (Solvents) ATMI Packaging Belgium Packaging Materials Bünder Glass Germany Injection Cartridges Foxboro The Netherlands Computer Systems PCLD Deventer The Netherlands Contract Manufacturing Octavius Hunt England Smoke Generators Pierre Guerin France Process Equipment CV-LvdB-July-2011 Page 6 of 6
Resume/CV: Ing. Leo van den Besselaar
Resume/CV: Ing. Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12,
van den Besselaar Mobile Phone no. : +31(0) 653796401 E-mail: leo.besselaar@lbqconsultancy.nl
Resume/CV Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963
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